EAACI Biologicals Guidelines—Omalizumab for the treatment of chronic spontaneous urticaria in adults and in the paediatric population 12–17 years old

Abstract

Chronic spontaneous urticaria (CSU) imposes a significant burden on patients, families and healthcare systems. Management is difficult, due to disease heterogeneity and insufficient efficacy of classical drugs such as H 1 R-antihistamines. Better understanding of the mechanisms has enabled a stratified approach to the management of CSU, supporting the use of targeted treatment with omalizumab. However, many practical issues including selection of responders, the definition of response, strategies to enhance the responder rate, the duration of treatment and its regimen (in the clinic or home-based) and its cost-effectiveness still require further clarification. The EAACI Guidelines on the use of omalizumab in CSU follow the GRADE approach in formulating recommendations for each outcome. In addition, future therapeutic approaches and perspectives as well as research priorities are discussed.

Efficacy of Different Dosing Regimens of IgE Targeted Biologic Omalizumab for Chronic Spontaneous Urticaria in Adult and Pediatric Populations: A Meta-Analysis

“…The UAS7 score is self-reported by the patient and is the gold standard for classifying patients as complete responders, partial responders, or non-responders [ 2 ]. UAS7 measures scores daily for seven consecutive days with two versions: once-daily documentation and the UAS7 TD with twice-daily documentation [ 32 ]. Both scores have high sensitivity to change and may be used to determine clinical response to treatment [ 33 ].…”

Urticaria

“…The management of urticaria has progressed substantially over the past two decades, with disease control possible for at least two-thirds of patients [144][145][146] . Increased understanding of disease pathogenesis underpins an expanding pipeline of targeted therapies with improved adverse effect profiles compared with traditional immunosuppressants (Table 3).…”

“…Lowered FcεRI expression may render the cells less susceptible to activation by IgE and IgG anti-FcεRI and prevent histamine release and inflammation 167 . As the step-up treatment from antihistamines, omalizumab, as an add-on therapy, has the strongest evidence base and recommendations of all possible treatments for CSU in patients ≥12 years of age 146 . A meta-analysis of 67 real-life CSU studies reported complete and partial response rates of 72% and 18%, respectively, comparable with efficacy in clinical trials, with a mean adverse effect rate of 4% 168 .…”

“…The use of sgAHs such as loratadine and cetirizine is also advised in breastfeeding women 4 , as nursing infants can develop sedation from first-generation antihistamines secreted into breast milk 194 . Omalizumab is reported safe in pregnancy 115,[195][196][197][198] and in younger children, although current licensing is for individuals aged 12 years and older 146 .…”

Ligelizumab impairs IgE‐binding to plasmacytoid dendritic cells more potently than omalizumab and restores IFN‐α production and FOXP3+ Treg generation

“…[1][2][3][4] Different biologicals targeting IgE have been developed and assayed as therapeutic strategies for such diseases. 5 Up to date, omalizumab, an IgG1 humanized monoclonal antibody (mAb) that binds free IgE with an affinity of 6.8 nM, is the only one approved for allergic asthma, 6 chronic spontaneous urticaria (CSU) [7][8][9] and chronic rhinosinusitis with nasal polyps (CRSwNP). 10 Omalizumab is a safe and effective treatment for many patients, but several limitations associated with its moderate affinity for IgE and its specific mode of action have been linked to the lack of efficacy reported for some patients and specific disease conditions.…”